Assessment of Hypotonia in Children With Down Syndrome

Completed

• Conditions: Muscle Hypotonia; Down Syndrome; Muscle, Floppy; CHILD Syndrome; Infant Floppy

• Registration Number: NCT05131542
• Lead Sponsor: Universidad de Murcia

Brief Summary

Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome.

Detailed Description

Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an instrument for early diagnosis, a systematic review was carried out which compiled characteristics and testing that are attributed to or used in the diagnosis of hypotonia. They were presented as an item group and a first stage was created and administered to 50 children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the results showed which characteristics were really related to the convention and which were more affected by changing factors. Then a final scale was developed that met the expected requirements of validity and reliability.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Primary Completion: 2021-12-31
• Status Verified: 2022-01
• Study Completion: 2022-01-15
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old

Read More

Exclusion Criteria

• Other hypotonic syndromes

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.	1 month	A study of homogeneity of the items was carried out to know if each item was measuring the same as the globality of the test. It was carried out by means of a reliability study of the statistics of each item compared to the total scale.
Analysis of the reliability of the scale	1 month	Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed
Content validity	1 month	It was done through expert judgment. It was reviewed by three physiotherapists with extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Empirical validity.	1 month	The correlation between the graduation of hypotonia derived from the scale and the observational diagnosis estimated by the evaluator was analyzed. An ANOVA test was used to compare both diagnostic assessments.extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Structural validity	In the process of analysis. 1 month to get results.	Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program.

Secondary Outcome Measures

Name	Time	Method
Descriptive analysis of the scale	1 month	Analyzing the values of standard deviation, mean, bias and kurtosis.
Analysis of the scale items.	1 month	An analysis of standard deviation, mean, correlation and Cronbach's alpha was performed for each item that made up the scale.
Frequency analysis of the items.	1 month	Frequency with which 0 (less hypotonia), 1 or 2 (greater hypotonia) each item of the scale has been scored.

Trial Locations

Locations (1)

University of Murcia; 🇪🇸 Murcia, Spain